UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061479 |
|---|---|
| Receipt number | R000070347 |
| Scientific Title | A Comprehensive MRI Evaluation of Structural and Physiological Changes in Lower Leg Tissue Associated with Compression from Compression Stockings |
| Date of disclosure of the study information | 2026/05/11 |
| Last modified on | 2026/05/07 18:27:35 |
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Basic information
Public title
A Comprehensive MRI Evaluation of Structural and Physiological Changes in Lower Leg Tissue Associated with Compression from Compression Stockings
Acronym
A Comprehensive MRI Evaluation of Structural and Physiological Changes in Lower Leg Tissue Associated with Compression from Compression Stockings
Scientific Title
A Comprehensive MRI Evaluation of Structural and Physiological Changes in Lower Leg Tissue Associated with Compression from Compression Stockings
Scientific Title:Acronym
A Comprehensive MRI Evaluation of Structural and Physiological Changes in Lower Leg Tissue Associated with Compression from Compression Stockings
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate structural and physiological changes in the skin, subcutaneous tissue, and skeletal muscle of the lower leg before and after wearing compression stockings in healthy volunteer, using quantitative MRI measures.
Basic objectives2
Others
Basic objectives -Others
Changes in tissue water dynamics and the electrolyte and energy metabolism environment before and after implantation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in various MRI-derived parameters before and after wearing compression stockings.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Putting on compression stockings
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Individuals aged 18 to 35 at the time of consent
2. Individuals without obvious edema, skin conditions, or injuries on the lower legs
3. Individuals capable of wearing compression stockings
4. Individuals who consent to undergoing an MRI examination and for whom safety during the MRI examination can be ensured
Key exclusion criteria
1. Individuals with metal devices or other foreign objects in their bodies due to past surgeries, or those for whom an MRI scan is difficult due to conditions such as claustrophobia
2. Individuals with deep vein thrombosis in the lower limbs, severe peripheral arterial disease, or conditions for which compression therapy is contraindicated
3. Pregnant women or women who may be pregnant
4. Individuals deemed unsuitable by the principal investigator
5. Individuals who have withdrawn their consent to participate in this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Iwanaga |
Organization
Fukushima Medical University
Division name
Department of Radiological Sciences, School of Health Sciences
Zip code
960-8516
Address
10-6 Sakae-machi, Fukushima
TEL
024-581-5577
iwanaga@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Iwanaga |
Organization
Fukushima Medical University
Division name
Department of Radiological Sciences, School of Health Sciences
Zip code
960-8516
Address
10-6 Sakae-machi, Fukushima
TEL
024-581-5577
Homepage URL
iwanaga@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
10-6 Sakae-machi, Fukushima
Tel
024-581-5577
iwanaga@fmu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 07 | Day |
Last modified on
| 2026 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070347
